IBEZA, LLC (Coral Gables, FL)

Accessing multiple databases that include medical information, and at least one standard for medical care is one way to assist a doctor in making a medically-related decision. Finding patient information within at least one database can be a part of this process regardless of where the patient is situated.

Systems and various types of software have been widely employed to aid medical professionals in the diagnosis of patient conditions, and to assist medical professionals in prescribing specific treatment options for thosediagnoses.

The medical system is an illustration. It was designed by the department of Accident and Emergency at Westminster Hospital in London. This system offers advice on the management of chest pain patients who are admitted to emergency rooms. A different medical software system is available under the brand name “ADE Monitor” and is being developed by the Washington University School of Medicine Department of Internal Medicine division of Medical Informatics. The system was designed to track patient data for potential adverse drug events. A similar medical software system is offered under the brand name “CADIAG-II” and was developed by the Department of Medical Computer Sciences. University ofVienna, the Department of Internal Medicine III, section of Rheumatology and the Department of Internal Medicine I, Divisions of Oncology. University of Vienna Medical School. This system is directed to colon diseases, and is a computer-assistedconsultation system to support the differential diagnostic process in internal medicine.

U.S. Published Patent Application No. 2002/0120471 was a recently published patent application. It describes a method for storing multiple medical guidelines for various health conditions and historical patient information. The information about the patient is collected via a global communication network, i.e., the Internet, and evaluated to provide a patient specific risk report based upon the medical guidelines contained in the database. The physician’s treatment plan could be generated to reduce risk for patients based on guidelines for medical care.

This method, however, can be a disadvantage since it permits a doctor to become reliant upon a system, instead of the physician’s own medical knowledge. Furthermore, the system is unable to check the performance of the physician in relation to whether the medical treatment recommended by the physician is proper. This system could result in a loss in resources.

U.S. Published Patent Application No. 2002/0143579, Docherty and al. This system highlights the potential for intervention by physicians to enhance prescribing practices and patient compliance. In particular, the system collects details about a doctor’s prescription practice, and analyzes that information with respect to guidelines from experts. The system detects deviations from the guidelines of experts and provides the physician with interventions information.

A method of assessing doctor performance, which includes a database to store the physician and patient contact is described in U.S. Pat. No. No. 5,924,073 for Tyuluman and co. To assess the data with statistical analysis, an evaluator has been attached to the database. This system may be used to define a set of standards for a particular element of patient population. The system is able to improve the standard of care to reflect more effective and efficient treatments. The system may additionally identify doctors that don’t meet the standards of care that are established. The systems, however, do not take into account the several standards that doctors must consider when prescribing medical treatment, i.e., hospital standards or medical standards, insurance standards, and so on.

U.S. Published Patent Application No. 2003/0055679 by Soll and al. A computerized patient management system that includes an individual patient module as well as a physician module, has been disclosed by Soll et . al. The system lets patients add their information to the module for patients. The database contains assessments and treatments for medical conditions data that are used to produce a report. The doctor can edit the report and add assessment and management plans. The physician may also choose educational materials for patients to be provided to the patient at an interview with the patient. However, this method relies on the ability of patients to enter their patient information correctly.

Given the background and context, the goal of the invention is to design an improved system for healthcare for patients by reducing medical errors. It is also a goal of the invention to provide a systemthat examines the medical treatment that patients receive as well as the performance of medical professionals in order to provide improved healthcare by reducing possible medical errors. It is further an object of the invention to monitor and report on the results of medical procedures. It is still further an objective of the invention to create a system to improve the efficiency of medical chart review and to speed up the process of receiving payment for medical treatment and medical services. It is a further object of the invention to provide secure indexing and search capabilities to ensure that patient information is easily found.

It is further an object of the present invention to create an instrument that significantly reduces the time it takes for an insurance company to make payments to a medical professional. The present invention also aims to give medical professionals current medical treatment information such as the most current medical standards and protocols. It is yet another object of the invention to cut down on the waste of medical resources.

These and other items, features, and advantages in accordance with the invention described herein are offered by a medical professional monitoring system with an interface for users that is in communication with a global communication network for use by amedical professional. The system can also include the patient database, a diagnosis database and the medical treatment database. Each database can be connected to a global communication network.

The database of patient information could include patient information for a plurality of patients registered with the medical professional. The medical treatment database can contain information that is available to medical professionals.

A server could be integrated within the system to connect with the global communications network. The server could also include an recording system that records the medical procedures selected by the physician. The system can also trackthe medical treatments selected by the physician to ensure compliance with a predetermined standard chosen from a variety of predetermined standards. The system helps in the training of medical professionals. This helps improve the patient’s care by reducing medical errors.

A standards database may be part of the system’s communications with the global network. The database of standards could include the various predetermined standards, and may be updateabie. The plurality of predeterminedstandards may, for example, be hospital standards, insurance standards, medical treatment standards, pharmaceutical standards, medical office standards, or emergency response standards. The system can coordinate practice guidelines from multiple sources like insurance and federal programs, hospitals, and other medical facilities, as well as medical practices, and medical experts.

The patient’s information, diagnosis , and medical treatment databases can be updated. The databases are able to be updated in a way that provides doctors with the most current medical information , and enhances the quality of medical treatment.

A reporting system may be integrated into the system to notify any physician who chooses to use the wrong treatment. The choice is compliant with at least one standard that is predetermined in the database of standards. The reporting agency could be notified if the medicalprofessional chooses the wrong treatment, which is not conforming to any of the standards that have been predetermined. The system of reporting can be beneficially enhanced to allow the system to be monitored by medical practitioners who choose treatment options which aren’t in line to predetermined standards. Medical professionals who are not in compliance could be urged to undergo training by the system of monitoring.

The system could also include a medical professional identification device for identifying the medical professionals that access the databases. The system may also include a notification system in communication with the global communicationsnetwork for notifying an insurance company of patient treatment. The notification system can help to reduce the time it takes doctors to receive reimbursement from their insurance providers for treatments they have ordered.

The medical professional could, for example, be an ophthalmologist, physician assistant, pharmacist, nurse or dietician, laboratory technician, or even an emergency response specialist. The system is advantageously adapted to be used by all medical professionals who have interaction with patients.

Monitoring the doctor is an aspect of the invention. This may involve granting medical professionals access to the patient information database as well as the diagnosis database as well as the medical treatmentdatabase. Monitoring the treatment selected by the professional to ensure compliance with minimum predetermined standard of the plethora of predetermined norms on the predetermined database may be a component of the method.

A method of selecting the appropriate medical treatment is an additional aspect of the invention. This could include retrieving and updating the patient’s data of a patient in an individual database of patients, and using diagnosis information from the diagnosis database, and then selecting the most appropriate medical treatment for the patient based on information about the diagnosis in the database. This could also comprise an evaluation of the selected medical treatment in relation to an existing medicaltreatment.

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What is a software medical device?

The FDA can refer to the functions of software that comprise ” Software As a Medical Device” and “Software in a Medical Device(SiMD), which are software that is integral (embedded within) a medical device.

Section 201(h),?21 U.S.C. 321(h)(1) defines the term “medical device” as instrument, apparatus, instrument, machine, contrivance implant, in vitro reagent, or other similar or related article, including a component or accessory that’s . . . (b) is intended to be used to diagnose illnesses or other conditions or in the cure, mitigation, treatment, or prevention of disease, in animals or man, or (c) designed to alter the structure or function of the human body or any other animal.? To be considered a medical device, and consequently subject to FDA regulations the software must satisfy at least one of the following criteria:

  • It should be used for the diagnosis and treatment of patients.
  • It should not be designed to alter the structure or the function of the body.

Thus, if your software is specifically designed for health professionals to treat and diagnose patients, or is used in hospitals to manage information about patients The FDA is likely to view the software as medical devices that are subject to review by the regulatory authorities.

Is Your Software a Medical Device?

According to FDA’s current approach to oversight which is based on the capabilities of the software higher than its platform, FDA will apply its regulatory oversight only to medical devices that have capabilities that be a risk to the safety of patients. Some examples of Device Software and Mobile Medical Apps FDA is focusing on

  • Software functions that aid patients with diagnosed psychiatric conditions (e.g. the post-traumatic stress disorder (PTSD), anxiety, depression, obsessive-compulsive disorder) maintain their behavioral strategies for coping by providing a “Skill of the Day” behavioral technique or audio-based messages users can use when they are experiencing an increase in anxiety;
  • Software functions that offer periodic educational information, reminders, or motivational advice for smokers who are trying to quit, patients recovering from addiction, and pregnant women;
  • Software functions that use GPS location information to alert asthmatics of conditions in the environment which could trigger asthma symptoms or notify an addict (substance addicts) in proximity to a specified high-risk or high-risk location.
  • Software functions that use video and video games to entice patients to perform their physical therapy exercises at home;
  • Software functions that ask the user to input the drug and herb they’d like to use simultaneously and give information on the likelihood of interactions being reported in the literature and a summary of what type of interaction was observed;
  • Software functions that make use of factors that affect the health of a patient, like age, sex and risk factors for behavioral health to offer specific screening for patients, counseling , and preventive advice from well-known and reputable authorities;
  • Software functions that utilize an inventory of typical symptoms and symptoms to provide guidance on when it is appropriate to see the doctor and what to do next.
  • Software functions that help users to complete a questionnaire about their symptoms and then provide a recommendation of the best health care facility for them.
  • Mobile apps are designed to allow a user to initiate a pre-specified nurse call or emergency call by using broadband or cell phone technology;
  • Apps that allow caregivers or patients to communicate emergency alerts to first responders using mobile phones
  • Software functions keep track of medicines and give users user-configured reminders to help improve compliance with medication;
  • Software functions that offer patients with access to their personal health information including access to data gathered at a previous visit to the doctor or the historical trending and comparison of vital indicators (e.g. body temperature, heart rate, blood pressure or respiration rate);
  • Software functions that display patterns in personal health incidents (e.g. rate of hospitalization or alert notification rate)
  • Software functions allow a user to collect (electronically or manually input) blood pressure data and send this information via e-mail, track and trend it, or even upload it to a personal or electronic health record;
  • Mobile apps that provide oral health reminders or tracking tools for users with gum disease.
  • Apps that give mobile users access to information and other tools for patients with prediabetes;
  • Applications that permit users to display messages and images on their smartphones, which could be utilized by substance abusers who want to quit addictive behaviors.
  • Software functions that provide drug-drug interactions and relevant safety data (side effects or drug interactions, active ingredient) in a form of a report, based on demographic data (age and gender) as well as clinical data (current diagnosis), and current medications; and
  • Software functions that provide the surgeon with a list of recommended intraocular lens powers and recommended an axis for implantation based upon information supplied by the surgeon (e.g. an expected surgically-induced astigmatism that is likely to occur, patient’s axial length and preoperative corneal astigmatism etc.)
  • Mobile apps, typically software that convert a mobile platform into a medical device that can be regulated.
  • Software that connects to a mobile device by using a sensor or lead that measures and displays the electrical signals generated by the heart (electrocardiograph, ECG).
  • Software that attaches sensors or other tool to the mobile platform in order to monitor and record eye movements in order to identify balance disorders
  • Software that gathers data about potential donors and sends the information to a blood collection facility. The software helps determine if a potential donor is eligible for blood collection or other components.
  • Software that connects to an existing device type in order to control the device’s operation, function or power source.
  • Software that alters the settings or functions of an infusion pump
  • Software that regulates inflation or deflation of the blood pressure cuff
  • Software that can calibrate hearing aids and evaluate the characteristics of sound intensity and the electroacoustic frequency of hearing aids.

What does it mean if your software/SaaS is classified as a medical device?

SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.

So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.

Software As Medical Device Patenting Considerations

The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.

Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.

In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.

The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.

When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.

An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.

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